Ketorolac Use and Fresh Embryo Transfer Outcomes

NCT07185724 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 202505454
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Ketorolac is a medication often used to relieve pain after surgery. In the past, infertility doctors have been cautious about using ketorolac after egg retrieval for patients planning a fresh embryo transfer (usually done 5 days later). The concern was that ketorolac might increase the risk of bleeding or reduce the chances of the embryo implanting in the uterus. This concern comes from how ketorolac works-it blocks certain chemicals in the body (like prostaglandins and thromboxane) that help with blood clotting and play a role in early pregnancy. However, a large review of past studies found no real evidence that ketorolac increases bleeding risk. In fact, ketorolac is now routinely used for pain relief in IVF cycles where embryos are frozen and not transferred right away. More recent studies from Boston and Chapel Hill have shown that ketorolac provides better pain control and does not appear to harm IVF outcomes, even when embryos are transferred fresh (within the same cycle). Despite these encouraging findings, many IVF clinics still avoid using ketorolac during fresh cycles because of the theoretical concerns. That's why we need stronger, higher-quality research. This study aims to fill that gap by conducting a double-blind randomized controlled trial to find out whether giving ketorolac through an IV after egg retrieval affects important IVF outcomes-especially the chance of implantation and live birth-in patients undergoing fresh embryo transfers. Patients who choose to join the study will randomly be placed into one of two groups. One group will get ketorolac (a pain medicine) after an IVF egg retrieval. The other group will not get ketorolac after egg retrieval. Everything else in their IVF care will stay the same as it normally would. Primary outcome will be implantation rate following fresh embryo transfers in patients receiving ketorolac (30mg IV) vs no ketorolac for post-retrieval analgesia. Secondary outcomes will include pain scale, narcotics required, time to discharge, need for evaluation w/in 24 hours for pain/bleeding, clinical pregnancy rates, miscarriage rates, and live birth rates following fresh embryo transfers in patients receiving ketorolac vs no ketorolac for post-retrieval analgesia.

Conditions

Infertility (IVF Patients); Infertility Treatment; Post-op Pain; Fresh Embryo Transfer; Oocyte Retrieval and Post Operative Pain Control

Keywords

IVF; post operative pain control; oocyte retrieval; fresh embryo transfer; ketorolac; toradol; implantation rate; live birth rate; miscarriage rate

Outcome Measures

Primary Outcomes (1)

• Implantation Rate

  Implantation rate following fresh embryo transfers in patients receiving ketorolac vs no ketorolac for post-retrieval analgesia. We define implantation rate as the proportion of transferred embryos which resulted in fetal heartbeat seen on ultrasound per patient.

  From enrollment to the time of confirmation of pregnancy ultrasound at ~6 weeks post-oocyte retrieval (with or without administration of IV Ketorolac) .

Secondary Outcomes (4)

• Clinical Pregnancy Rate

  From enrollment to the time of confirmation of pregnancy ultrasound at ~6 weeks post-oocyte retrieval (with or without administration of IV Ketorolac) .

• Miscarriage Rate

  From date of enrollment through first documented instance of miscarriage up to 40 weeks.

• Live Birth Rate

  From enrollment to the end of pregnancy (~40 weeks) resulting from fresh embryo transfer following the oocyte retrieval in which patient received IV Ketorolac or no IV Ketorolac.

• Post-operative Pain

  From enrollment until the time of discharge from oocyte retrieval (~2.5 hours).

Study Arms (2)

IV Ketorolac

EXPERIMENTAL

Participants randomized to this arm will receive 30mg IV Ketorolac at the conclusion of their oocyte retrieval.

Drug: Ketorolac 30 mg IV

No IV Ketorolac

NO INTERVENTION

Participants randomized to this arm will not receive IV Ketorolac at the conclusion of their oocyte retrieval.

Interventions

Ketorolac 30 mg IV DRUG

We will be evaluating the effect of post-oocyte retrieval ketorolac administration on clinical outcomes in fresh embryo transfer cycles.

IV Ketorolac

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• IVF utilizing autologous oocytes and all sperm sources
• IVF cycles utilizing ICSI and standard insemination
• Plan to transfer embryo on day 5
• BMI below 50

You may not qualify if:

• allergies or medical contraindications to NSAIDs

Sponsors & Collaborators

• Jessica D. Kresowik: lead

Study Sites (1)

UI Health Care Center for Advanced Reproductive Care

Iowa City, Iowa, 52245, United States

RECRUITING

Related Publications (3)

• Mesen TB, Kacemi-Bourhim L, Marshburn PB, Usadi RS, Matthews M, Norton HJ, Hurst BS. The effect of ketorolac on pregnancy rates when used immediately after oocyte retrieval. Fertil Steril. 2013 Sep;100(3):725-8. doi: 10.1016/j.fertnstert.2013.04.048. Epub 2013 May 28.

  PMID: 23721715 BACKGROUND

• Gobble RM, Hoang HLT, Kachniarz B, Orgill DP. Ketorolac does not increase perioperative bleeding: a meta-analysis of randomized controlled trials. Plast Reconstr Surg. 2014 Mar;133(3):741-755. doi: 10.1097/01.prs.0000438459.60474.b5.

  PMID: 24572864 BACKGROUND

• Waljee JF, Li L, Brummett CM, Englesbe MJ. Iatrogenic Opioid Dependence in the United States: Are Surgeons the Gatekeepers? Ann Surg. 2017 Apr;265(4):728-730. doi: 10.1097/SLA.0000000000001904. No abstract available.

  PMID: 27429023 BACKGROUND

MeSH Terms

Conditions

Infertility; Pain, Postoperative

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Jessica Kresowik, MD

CONTACT

563-355-2244; jessica-kresowik@uiowa.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, investigator, IVF provider, nursing team, and all members involved in assessing outcomes will be blinded. Patient will be under anesthetic influence and be unaware of medication administration. Recovery nurse and surgeon will not be aware or informed of treatment arm. Anesthesia will be unblinded but will not inform any other members of the medical team whether or not patient received ketorolac.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 22, 2025
• Study Start: November 8, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1)